Novo Nordisk obesity treatment successful in clinical trials

pharmafile | March 24, 2021 | News story | Research and Development Novo Nordisk, obesity 

New results from Novo Nordisk’s Phase III study on obesity saw clinically relevant weight loss, without weight regain, in people treated with a 2.4mg dose of semaglutide versus a placebo in combination with lifestyle intervention.

The full results of the clinical trial were presented at the virtual Endocrine Society (ENDO) 2021 Annual Meeting and published in the Journal of the American Medical Association on Tuesday.

The study involved two trials, STEP and STEP 4, spanning a total of 68 weeks designed to assess the effect of continuing versus discontinuing semaglutide at 2.4mg in adults with obesity. In the STEP 4 trial, study participants who reached the maintenance dose of semaglutide at 2.4mg during a 20-week run-in period were randomised to either continue treatment with semaglutide or switch to placebo for 48 weeks.

Following the 20-week run-in period, people who continued treatment with semaglutide for an additional 48 weeks continued to lose weight with a statistically significant additional mean weight loss of 7.9% from week 20 to week 68. Whereas people who were switched to placebo following the run-in period regained 6.9% of their body weight from week 20 to 68. People who stayed on semaglutide throughout the entire 68-week trial achieved a total weight loss of 17.4%.

Martin Holst Lange, Executive Vice President of Development at Novo Nordisk, said: “Obesity is a chronic disease that requires ongoing management and the results from STEP 4 trial strengthens the evidence around the potential of semaglutide 2.4mg to transform the medical management of obesity.

“Millions of people living with obesity are in need of additional treatment options to help them lose weight and keep it off. The results from STEP 4 show that to sustain weight loss it is important to maintain treatment and that semaglutide 2.4mg has the potential to offer sustained weight loss of more than 17% after 68 weeks of treatment.”

The semaglutide 2.4mg safety profile is in line with observations seen previously with GLP-1 receptor agonists. It is generally well-tolerated, and the most common adverse events among people treated with semaglutide 2.4mg were gastrointestinal events.

Dr Domenica Rubino, Lead Investigator of the STEP 4 trial and Director of Washington Center for Weight Management and Research, said: “For people with obesity, maintaining weight loss in the long term is challenging as both physiological and hormonal changes that occur following an initial weight loss can lead to weight regain. These changes, known as metabolic adaptation, result in lasting increased levels of hunger and desire to eat while reducing energy expenditure.

“Like any other chronic disease, obesity requires a long-term, individualised approach to care, inclusive of medication and lifestyle components.”

Kat Jenkins

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